- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05327634
Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network (OUTMEDIC-FR)
Description of the Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network
Study Overview
Detailed Description
For several years now, the proportion of senior citizens in our country has been rising steadily. There are now 6.4 million people over the age of 75 in France.
It is therefore important to take into account the needs and specificities of this part of the population. One of its particularities is polypathology. Indeed, from the age of 70 onwards, 93% of elderly subjects have at least 2 diseases and 85% have at least 3. This polypathology will lead to a large number of different prescribers with an increased risk of having more than 5 molecules in their personal treatment. This is known as polypharmacy.
In the elderly, polypharmacy is harmful. It increases the risk of adverse effects and drug interactions. In France, 20% of patients over 75 years old and 25% of those over 85 years old consult the emergency room because of adverse drug reactions.
The literature shows that we can act on these adverse events by "deprescribing". De-prescribing is defined as intentionally stopping the prescription of an unnecessary or potentially dangerous drug for a patient.
The expected benefit for the patient is to reduce the iatrogenic risks induced by treatments that would no longer be useful for him/her or that have a negative benefit/risk balance. To achieve this objective, the patient must understand this risk, understand the benefit he or she can derive from it and be an actor in this process.
For carers, the expected benefit is greater involvement of the patient in the process, better adherence to the approach, which can be organised and carried out in a safer way.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Beauvais, France, 60021
- Short stay Geriatric department - Hospital Simone Veil
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Beauvais, France, 60021
- SSR Geriatric department - Hospital Simone Veil
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Pontoise, France, 95300
- Short stay Geriatric department - Hospital René Dubos
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Pontoise, France, 95300
- SSR Geriatric department - Hospital René Dubos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 75 years and over
- Hospitalized in geriatric short-stay or geriatric rehabilitation units
- Patients who did not object to participation in the study
Exclusion Criteria:
- Patient refusal
- Patients not able to understand and fill in the questionnaire: Cognitive disorders, Confusion, Unstable clinical state, Sensory disorders, not speaking French.
- Patient under protective supervision (guardianship or curatorship)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Deprescribing
Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units
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Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of the obstacles to the withdrawal of medication in patients over 75 years of age in the geriatric sector
Time Frame: Baseline
|
The main evaluation criterion will be measured using the self-questionnaire: a revised form of the 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD), validated in French. Discouragement will be assessed on the basis of the overall score of questions 1 to 20 of the self-questionnaire, with regard to questions 21 and 22. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the relationship between patient burden and acceptance (or refusal) of deprescribing.
Time Frame: Baseline
|
They will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items. They will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items. |
Baseline
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Assessment of the relationship between the benefit of the treatment experienced by the patient and the acceptance (or refusal) of the deprescribing
Time Frame: Baseline
|
They will be measured using the self-questionnaire given to patients.
Responses to the questions concerning the perceived benefit of treatment (questions 6 to 10) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale.
A correlation will be made between the two items
|
Baseline
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Assessment of the relationship between concern about possible negative effects of discontinuing treatment and acceptance (or refusal) of deprescribing
Time Frame: Baseline
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They will be measured using the self-questionnaire given to patients.
Responses to questions concerning concern about possible negative effects of stopping treatment (questions 11 to 15) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale.
A correlation will be made between the two items.
|
Baseline
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Assessment of the relationship between the patient's good knowledge of their treatments and acceptance (or refusal) of the deprescribing.
Time Frame: Baseline
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They will be measured using the self-questionnaire given to patients.
The answers to the questions concerning the patient's good knowledge of their treatments (questions 16 to 20) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale.
A correlation will be made between the two items..
|
Baseline
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Assessment of the relationship between certain families of treatments and acceptance (or refusal) of deprescribing
Time Frame: Baseline
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They will be measured using the self-questionnaire given to patients.
Responses concerning the acceptance of deprescribing according to the different treatment families will be measured using simple questions 26 to 29 of the self-questionnaire
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe Antoniazzi, Hospital René Dubos
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHRD2921
- 2022-A00136-37 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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